Condition category
Nutritional, Metabolic, Endocrine
Date applied
05/09/2005
Date assigned
16/09/2005
Last edited
14/10/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Peter Kopelman

ORCID ID

Contact details

Barts and The London
Queen Mary's School of Medicine & Dentistry
30-32 Newark Street
London
E1 2AA
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ATL-962/175/CL, orlistat

Study information

Scientific title

Acronym

Study hypothesis

Does ATL-962 induce weight loss in diabetic patients and is its safety and tolerability profile superior to that of orlistat in such patients?

Ethics approval

Not provided at time of registration

Study design

Randomised three arm placebo controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Obesity in patients with Type II diabetes

Intervention

ATL-962 (40 mg, 80 mg, or 120 mg), or placebo, or orlistat (120 mg) three times a day for 12 weeks

Intervention type

Drug

Phase

Not Specified

Drug names

ATL-962 (cetilistat), orlistat, metformin

Primary outcome measures

Absolute weight loss compared to baseline

Secondary outcome measures

Proportion of patients achieving 5% or 10% weight loss; changes in waist circumference; changes in lipid profiles; changes in markers of diabetes; incidence of GI adverse events; changes in other safety parameters

Overall trial start date

01/12/2004

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Type II diabetic patients
2. Aged 18-65
3. Body Mass Index (BMI) between 28 kg/m2 and 45 kg/m2
4. Glycosylated haemaglobin (HbA1c) value between 6% and 10%
5. Being treated with a stable dose of metformin

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

600 patients randomised

Participant exclusion criteria

1. Significant weight loss in the previous 3 months
2. Weight gain during the run-in period
3. Other serious systemic disease, except for controlled hypertension, mild asthma, and primary hypothyroidism
4. History of GI disorders
5. Previous surgery for weight loss

Recruitment start date

01/12/2004

Recruitment end date

30/06/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Barts and The London
London
E1 2AA
United Kingdom

Sponsor information

Organisation

Alizyme (UK)

Sponsor details

Granta Park
Great Abington
Cambridge
CB1 6GX
United Kingdom
+44 (0)1223 896 000
Medical.Information@alizyme.co.uk

Sponsor type

Industry

Website

http://www.alizyme.com

Funders

Funder type

Industry

Funder name

Alizyme (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19461584

Publication citations

  1. Results

    Kopelman P, Groot Gde H, Rissanen A, Rossner S, Toubro S, Palmer R, Hallam R, Bryson A, Hickling RI, Weight loss, HbA1c reduction, and tolerability of cetilistat in a randomized, placebo-controlled phase 2 trial in obese diabetics: comparison with orlistat (Xenical)., Obesity (Silver Spring), 2010, 18, 1, 108-115, doi: 10.1038/oby.2009.155.

Additional files

Editorial Notes